12Pin 12-Lead Host Cable

GUDID 06944904097992

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Electrocardiographic lead set, reusable

• Primary Device ID: 06944904097992
• NIH Device Record Key: e65db15f-d3df-4f3f-bea2-c23a37073489
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 12Pin 12-Lead Host Cable
• Version Model Number: 040-003528-00
• Company DUNS: 654671304
• Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +8675581888998
• Email: service@mindray.com.cn

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904097992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182075

FDA Product Code

• DRW: Adaptor, Lead Switching, Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-07
• Device Publish Date: 2020-04-29

Devices Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

• 06944904031408 - BC-6D Hematology Control: 2023-10-27
• 06944904031422 - BC-RET Hematology Control: 2023-10-27
• 06903053039673 - L9-3s Transducer(FDA-SJM): 2023-05-30
• 06903053039680 - P8-2Ts Transducer(FDA-SJM): 2023-05-30
• 06903053039697 - SP5-1s Transducer(FDA-SJM): 2023-05-30
• 06903053039703 - P8-2s Transducer(FDA-SJM): 2023-05-30
• 06903053039710 - CW2s Transducer(FDA-SJM): 2023-05-30
• 06903053039727 - L16-4Hs Transducer(FDA-SJM): 2023-05-30